Ventricular Assist Devices (VAD) and Total Artificial Hearts (TAH)
DESCRIPTION
Ventricular assist devices (VAD) provide mechanical circulatory support to compensate for the diminished ability of the heart to pump blood in individuals with acute heart failure or advanced chronic heart failure. The VAD is used to sustain individuals awaiting heart transplantation and to facilitate cardiac recovery in individuals suffering from reversible cardiac dysfunction. More recently given their success for prolonged periods of time the device is now being utilized as “destination” therapy to provide permanent circulatory support in individuals with end stage cardiac disease who are not candidates for transplant.
The total artificial heart (TAH) is a pulsatile biventricular device that is implanted in the thoracic cavity to temporarily replace both native cardiac ventricles and all cardiac valves. The device is intended to act as a bridge to heart transplantation and perform the pumping function of a natural heart for an individual who is eligible for a cardiac transplantation and at risk of imminent death from biventricular failure.
The FDA has approved a variety of devices to be used as ventricular assist devices and total artificial hearts for destination therapy and also for bridge to transplant care. The FDA has approved one VAD for the pediatric population (age 5-16) who are awaiting transplant.
POLICY
Ventricular assist devices as a bridge to transplant, destination therapy, or recovery support in post cardiotomy setting are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Total artificial hearts used as a bridge to heart transplantation are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Other applications of left ventricular devices or total artificial hearts are considered investigational, including but not limited to the use of total artificial hearts as destination therapy.
Any ventricular assist device or total artificial heart utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
See also:
MEDICAL APPROPRIATENESS
Ventricular assist devices are considered medically appropriate if ANY ONE of the following criteria are met:
As a bridge to heart transplantation for individuals with end-stage heart failure and ALL of the following criteria are met:
Diagnosis of severe congestive heart failure and approved heart transplantation candidate on the transplantation list
Meets the selection criteria for Heart Transplantation - Please refer to the Milliman Care Guidelines - Heart Transplant guideline.
Imminent risk of dying before donor heart procurement
Receiving optimal medical management (e.g. inotropic support and/or intra-aortic balloon pump)
ABSENCE of ALL:
Presence of other clinically significant conditions (including but not limited to irreversible hepatic or renal dysfunction, respiratory failure, unresolved recent malignancy limiting life expectancy, systemic infection)
Uncorrected valvular disease (this is due to potential problems with adequate function of the VAD)
Coagulation disorders
As a bridge to transplant for pediatric individuals (age 5-16) if ALL of the following are met:
Currently listed as a heart transplant candidate
The device is FDA approved or cleared with the humanitarian device exemption (HDE)
Is not expected to survive until a donor heart can be obtained
As
destination therapy for individuals with end-stage heart failure who are
ineligible for human heart transplant and ALL
of the following criteria are met:
(Note: The
NYHA classification criteria below do not apply to Medicare members. Please
refer to the Medicare policy for their NYHA based criteria.)
New York Heart Association (NYHA) classification for heart failure with ANY ONE of the following:
NYHA Class IV for more than 60 days
NYHA class III/IV for more than 28 days with ANY ONE of the following:
has received greater than 14 days support with intra-aortic balloon pump
remains dependent on IV inotropic agents after 2 failed weaning attempts
Demonstrated functional limitation with a peak oxygen consumption of less than 14 ml/kg/min
ABSENCE of ALL of the following contraindications:
Chronic renal failure (Serum creatinine greater than 2.5 mg/dl for more than 90 days)
Insulin dependent diabetes with end organ damage
Presence of other clinically significant conditions (including but not limited to irreversible hepatic or renal dysfunction, respiratory failure, unresolved recent malignancy limiting life expectancy, systemic infection)
Uncorrected valvular disease (potential problems with optimal function of the VAD)
Coagulation disorders
In the post-cardiotomy setting for individuals who cannot be weaned off cardiopulmonary bypass
Total artificial heart as a bridge to heart transplantation is considered medically appropriate if ALL of the following criteria are met:
The individual is in imminent risk of death from biventricular failure with no other appropriate medical or surgical options
Is an approved heart transplant candidate on the transplantation list
Meets the selection criteria for Heart Transplantation - Please refer to the Milliman Care Guidelines - Heart Transplant guideline.
Has sufficient space in the chest area vacated by the natural ventricles (generally body surface areas greater than 1.7 m2 and a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging greater than or equal to 10cm) to support the TAH
Absence of coagulation disorders
Absence of other clinically significant conditions (including but not limited to irreversible hepatic or renal dysfunction, respiratory failure, unresolved recent malignancy limiting life expectancy, systemic infection)
Is ineligible for other univentricular or biventricular devices
Is not expected to survive until a donor heart can be obtained
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
New York Heart Association Classification
|
Class I |
Patients with objective evidence of cardiac disease but without limitation of physical activity. Ordinary activity does not cause undue fatigue, palpitation, dyspnea or anginal pain. |
|
Class II |
Patients with objective evidence of cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. |
|
Class III |
Patients with objective evidence of cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. |
|
Class IV |
Patients with objective evidence of cardiac disease resulting in inability to carry on physical activity. |
There is inadequate scientific evidence to permit conclusions regarding the use of ventricular assist devices or total artificial hearts for other conditions or disease including, but not limited to the use of total artificial hearts as destination therapy.
SOURCES
American Heart Association. Classification of functional capacity and objective assessment. Retrieved from http://www.americanheart.org/presenter.jhtml?identifier=4569.
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2010). Total artificial heart and implantable ventricular assist devices. (7.03.11). Retrieved November 2, 2010 from BlueWeb. (30 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2010,April). Artificial hearts and related devices (NCD 20.9, p. 2-16 to 2-17). Ingenix.
Frazier, O., & Jacob. L. (2007). Small pump for ventricular assistance: Progress in mechanical circulatory support. Cardiology Clinics, 25 (2007), 553-564. (Level 5 Evidence)
Leitz, K., Long, J., Kfoury, A., Slaughter, M., Silver, M., Milano, C., et al. (2007) Outcomes of left ventricular assist device implantation as destination therapy in the post REMATCH era: Implications for patient selection. Retrieved November 4, 2010 from http://circ.ahajournals.org/cgi/reprint/116/5/497.
Mancini, D., Lietz, K. (2010). Selection of cardiac transplantation candidates in 2010. Retrieved September 29, 2010 from http://circ.ahajournals.org/cgi/reprint/122/2/173.
Mehra, M., Kobashigawa, J., Starling, R., Russell, S., Uber, P., Parameshwar, J., et al. (2006) Listing criteria for heart transplantation: International society for heart and lung transplantation guidelines for the care of cardiac transplant candidates – 2006. Retrieved August 27, 2010 from http://www.jhltonline.org/article/PIIS1053249806004608/fulltext.
National Institute of Clinical Excellence. (2006, June). Short term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery. Retrieved August 26, 2010 from http://www.nice.org.uk/nicemedia/live/11049/30742/30742.pdf.
U.S. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Proposed decision memo for ventricular assist devices as destination therapy (CAG-00119R2). Retrieved August 31, 2010 from http://www.cms.gov/mcd/viewdraftdecisionmemo.asp?id=243.
U.S. Food and Drug Administration. (2004, February). Center for Diseases and Radiological Health. Humanitarian device exemption H-030003. Retrieved August 27, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/H030003a.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2010, August; last update search August 2010). Left ventricular assist devices (LVAD) in adult patients with chronic end-stage heart failure. Retrieved August 26, 2010 from www.Hayesinc.com/subscribers. (124) articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1996
MOST RECENT REVIEW DATE: 1/13/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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